Orthopaedic plate and screw assembly

ABSTRACT

Systems, devices and methods are disclosed for treating fractures and other bone maladies. The systems, devices and methods may include one or both of a stabilizing structure, such as an implant, bone plate, or other device and a fastening assembly, such as a lag screw and compression screw assembly. The stabilizing structure in some embodiments has a proximal section with a transverse aperture and a cross-section that may be shaped to more accurately conform to the anatomical shape of cortical bone and to provide additional strength and robustness in its lateral portions, preferably without requiring significant additional material. The fastening assembly may be received to slide, in a controlled way, in the transverse aperture of the stabilizing structure. In some embodiments, the engaging member and the compression member are configured so that the compression member interacts at least indirectly with the stabilizing structure and a portion of the engaging member to enable controlled movement between the first and second bone fragments. This configuration is useful for, among other things, compressing a fracture.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.10/937,075, filed Sep. 8, 2004 for an “Orthopaedic Plate and ScrewAssembly,” which was a continuation of U.S. application Ser. No.10/658,351, filed Sep. 8, 2003 for an “Orthopaedic Implant and ScrewAssembly,” the entire contents of both of which are incorporated by thisreference. This application also claims the benefit of U.S. provisionalapplication Ser. No. 60/783,931, filed Mar. 20, 2006 for an “OrthopaedicPlate and Screw Assembly,” the entire contents of which are incorporatedby this reference.

RELATED FIELDS

Embodiments of the present invention generally relate to systems forcoupling bone portions across a fracture and, more specifically, tointramedullary nail or plate and screw assemblies or other stabilizingstructures and fastening assemblies used to treat fractures of longbones, such as the femur, humerus, tibia, and various periarticularfractures of these and other bones.

BACKGROUND

There are a variety of devices used to treat fractures of the femur,humerus, tibia, and other long bones. For example, fractures of thefemoral neck, head, and intertrochanteric region have been successfullytreated with a variety of compression screw assemblies, which includegenerally a compression plate having a barrel member, a lag screw and acompressing screw. Examples include the AMBI® and CLASSIC® compressionhip screw systems offered by Smith & Nephew, Inc. In such systems, thecompression plate is secured to the exterior of the femur, and thebarrel member is inserted in a predrilled hole in the direction of thefemoral head. The lag screw has a threaded end, or another mechanism forengaging bone, and a smooth portion. The lag screw is inserted throughthe barrel member so that it extends across the break and into thefemoral head. The threaded portion engages the femoral head. Thecompression screw connects the lag screw to the plate. By adjusting thetension of the compression screw, the compression (reduction) of thefracture can be varied. The smooth portion of the lag screw is free toslide through the barrel member to permit the adjustment of thecompression screw. Some assemblies of the prior art use multiple screwsto prevent rotation of the lag screw relative to the compression plateand barrel member and also to prevent rotation of the femoral head onthe lag screw.

Intramedullary nails in combination with lag screws or other screwassemblies have been successfully used to treat fractures of the femur,humerus, tibia, and other long bones as well. A significant applicationof such devices has been the treatment of femoral fractures. One suchnailing system is the IMHS® system offered by Smith & Nephew, Inc., andcovered at least in part by U.S. Pat. No. 5,032,125 and various relatedinternational patents. Other seminal patents in the field include U.S.Pat. Nos. 4,827,917, 5,167,663, 5,312,406, and 5,562,666, which are allassigned to Smith & Nephew, Inc. A typical prior art intramedullary nailmay have one or more transverse apertures through its distal end toallow distal bone screws or pins to be screwed or otherwise insertedthrough the femur at the distal end of the intramedullary nail. This iscalled “locking” and secures the distal end of the intramedullary nailto the femur. In addition, a typical intramedullary nail may have one ormore apertures through its proximal end to allow a lag screw assembly tobe screwed or otherwise inserted through the proximal end of theintramedullary nail and into the femur. The lag screw is positionedacross the break in the femur and an end portion of the lag screwengages the femoral head. An intramedullary nail can also be used totreat shaft fractures of the femur or other long bones.

As with compression hip screw systems, intramedullary nail systems aresometimes designed to allow compression screws and/or lag screws toslide through the nail and thus permit contact between or among the bonefragments. Contact resulting from sliding compression facilitates fasterhealing in some circumstances. In some systems, two separate screws (orone screw and a separate pin) are used in order, among other things, toprevent rotation of the femoral head relative to the remainder of thefemur, to prevent penetration of a single screw beyond the femoral head,and to prevent a single screw from tearing through the femoral neck andhead. When an additional screw or pin is used, however, unequal forcesapplied to the separated screws or pins can cause the separate screws orpins to be pressed against the sides of the holes through which theseparate screws or pins are intended to slide. This may result inbinding, which reduces the sliding of the screws or pins through thenail. Conversely, a problem can result from excessive compression of thefemoral head toward or into the fracture site. In extreme cases,excessive sliding compression may cause the femoral head to becompressed all the way into the trochanteric region of the femur.

Furthermore, overly rigid nails sometimes generate periprostheticfractures in regions away from a fracture site. Therefore, it isimportant that intramedullary nails be adequately flexible in comparisonto the bones in which they are implanted.

The harder, generally outer portion of a typical bone is referred to ascortical bone. Cortical bone is usually a structurally soundload-bearing material for support of an implant. A cross-section of along bone that shows the typical anatomical shape of cortical bonegenerally reveals a non-circular ring of cortical bone which surrounds amedullary canal. Accordingly, the medullary canal generally features anon-circular cross section. Intramedullary nails of the prior art,however, are usually round or square in cross-section, and therefore notanatomically consistent with the cortical bone or the medullary canal.Some have addressed this problem by reaming the medullary canal of thebone with a round reamer in order to cause the nail to fit the corticalbone. This approach, however, can remove significant portions of healthycortical bone.

The problem of providing an effective load bearing physical relationshipbetween an implant and cortical bone in the proximal femur has beenaddressed in the art of hip replacement devices. Various hip stems havebeen developed which feature generally non-circular cross sections alongtheir length, in order better to fit the anatomically shaped corticalbone of the proximal femur and thus more evenly and effectivelydistribute the load between the stem and the bone. However, none ofthese hip stems have been incorporated into a nail, bone plate, or otherimplant or stabilizing structure, nor have they been configured toaccept a screw or screws useful in repairing substantially all of theportions of the treated bone. Instead, hip stems as a general matterhave been considered as a device for replacing portions of a long bone,and designed and used for that purpose. For example, the typicalapplication of a hip stem includes completely removing a femoral headand neck, implanting a hip stem, and using the hip stem to support anartificial femoral head.

In summary, and without limitation, the foregoing shows some of theshortcomings of the state of the art in this field. Among other things,what is needed is an orthopaedic system that includes a superior slidingscrew or other mechanism for applying compression across a fracture.Some embodiments would also provide a sliding screw or other mechanismthat obtains adequate bone purchase while reducing the incidence ofcut-out, rotational instability, and excessive sliding. An anatomicallyappropriately shaped implant or other stabilizing structure forachieving improved cortical bone contact would also be advantageous.Where the stabilizing structure is an intramedullary nail implant, thenail would provide for reduced reaming and removal of healthy bone. Animproved stabilizing structure may also have a cross-section thatprovides a greater area of material on the side of the device that isplaced under a greater tensile load when it is subjected to a typicalbending load. Additionally, an improved orthopaedic system could includea sliding screw in combination with intramedullary nails of variousdesigns, or in combination with plates or other stabilizing structures.Combinations of any of these with each other, and/or with other devicesor combinations of them also present opportunities for advancementbeyond the state of the art according to certain aspects and embodimentsof the present invention.

SUMMARY

Methods, devices and systems according to certain aspects of thisinvention allow treatment of bone fractures and other types of maladiesusing one or both of a stabilizing structure for association with afirst bone fragment and a fastening assembly for association with asecond bone fragment. The stabilizing structure may be a plate or otherdevice for at least partial application to the outer surface of bone, oran implant for at least partial implantation within bone. Suchstabilizing structures may include a proximal section having atransverse aperture.

In some embodiments, one or more cross sections of the proximal sectionmay feature shapes that impart additional strength and resistance totension. Such shapes can be provided, for instance, by one or both (i)adding additional mass in lateral portions of the cross section, and (2)strategically adding and reducing mass in the cross section to takeadvantage of flange effects similar to the way flanges add structuralbenefits to I-beams and channels. One way to characterize suchcross-sections, which can but need not be asymmetrical with respect toat least one axis, is that they generally feature a moment of inertiaextending in a lateral direction from a point that is the midpoint of aline from a lateral tangent to a medial tangent of the cross section. Insome structures, that line is coplanar with the axis of the transverseaperture and coplanar with the cross section and thus defined by theintersection of those planes. The endpoints of that line can be definedas the intersection of the line with tangents to the medial aspect andthe lateral aspect of the cross section, respectively. In someembodiments, such stabilizing structures may also include a transitionsection to provide a coupling between proximal and distal sections ofthe stabilizing structure. In other embodiments, it is not necessarythat the stabilizing structure include these geometries and/orproperties.

Fastening assemblies of methods, devices and systems according tocertain embodiments of the invention may at least partially extendthrough the transverse aperture of the stabilizing structure and mayinclude an engaging member and a compression member. The engaging membermay be a lag screw or other similar device used to gain purchase in orotherwise engage a second bone fragment. The engaging member may be ableto slide with respect to the transverse aperture of the stabilizingstructure. The engaging and compression members may be configured suchthat the compression member at least indirectly interacts with a portionof the stabilizing structure as well as a portion of the engaging memberto enable controlled movement between the first and second bonefragments. In some embodiments, the compression member at leastpartially directly contacts the second bone fragment.

In some embodiments, methods, devices, and systems of the presentinvention include an insert received in the stabilizing structure'stransverse aperture that includes another transverse aperture. In suchembodiments, the fastening assembly may at least partially extendthrough the second transverse aperture.

According to an aspect of the present invention, there may be providedan apparatus for treating bone maladies, including a stabilizingstructure associated with a first bone portion, the stabilizingstructure including a first transverse aperture; a fastening assembly atleast partially extending through the first transverse aperture, thefastening assembly including an engaging member and a compressionmember: the engaging member engaging a second bone portion; thecompression member contacting and interacting with the engaging member;the compression member contacting the second bone portion; and thecompression member at least indirectly interacting with the stabilizingstructure; and an insert at least partially extending through the firsttransverse aperture and including a second transverse aperture; thefastening assembly at least partially extending through the secondtransverse aperture.

According to some embodiments of the present invention, the compressionmember facilitates a sliding movement of the engaging member withrespect to the first transverse aperture; and the compression memberfacilitates a controlled movement between the first and second boneportions.

According to some embodiments of the present invention, the compressionmember at least indirectly interacts with the insert to facilitatecontrolled movement between the first and second bone portions.

According to some embodiments of the present invention, the compressionmember includes a shoulder that abuts against a portion of the insert.

According to some embodiments of the present invention, the controlledmovement between the first and second bone portions includes substantialpreclusion of rotation of the first and second bone portions withrespect to one another.

According to some embodiments of the present invention, the controlledmovement between the first and second bone portions includes compressingthe first and second bone portions with respect to one another.

According to some embodiments of the present invention, adjusting thecompression member tensions the engaging member to compress the firstand second bone portions with respect to one another.

According to some embodiments of the present invention, the compressionmember is at least partially nested within a portion of the engagingmember.

According to some embodiments of the present invention, the compressionmember includes a first threaded portion and the engaging memberincludes a second threaded portion; wherein the first and secondthreaded portions cooperate with one another such that adjusting thecompression member tensions the engaging member to compress the firstand second bone portions with respect to one another.

According to some embodiments of the present invention, the insert snapsinto the first transverse aperture.

According to some embodiments of the present invention, an arm interactswith an indention to facilitate the insert snapping into the firsttransverse aperture.

According to some embodiments of the present invention, a ridge memberinteracts with an indention to facilitate the insert snapping into thefirst transverse aperture.

According to another aspect of the present invention, there may beprovided an apparatus for treating bone maladies, including stabilizingstructure associated with a first bone portion, the stabilizingstructure including a transverse aperture; a fastening assembly at leastpartially extending through the first transverse aperture, the fasteningassembly including an engaging member and a compression member, whereinthe engaging member engages a second bone portion, wherein thecompression member contacts and interacts with the engaging member,wherein the compression member contacts the second bone portion, whereinthe compression member facilitates a sliding movement of the engagingmember with respect to the first transverse aperture, wherein thecompression member at least indirectly interacts with the stabilizingstructure to facilitate controlled movement between the first and secondbone portions, and wherein the controlled movement comprises substantialpreclusion of rotation of the first and second bone portions withrespect to one another as well as compressing the first and second boneportions with respect to one another; and an insert at least partiallyextending through the first transverse aperture and including a secondtransverse aperture; wherein the fastening assembly at least partiallyextends through the second transverse aperture.

According to some embodiments of the present invention, the compressionmember at least indirectly interacts with the insert to facilitatecontrolled movement between the first and second bone portions.

According to some embodiments of the present invention, the compressionmember includes a shoulder that abuts against a portion of the insert.

According to some embodiments of the present invention, adjusting thecompression member tensions the engaging member to compress the firstand second bone portions with respect to one another.

According to some embodiments of the present invention, the compressionmember is at least partially nested within a portion of the engagingmember.

According to some embodiments of the present invention, the compressionmember includes a first threaded portion and the engaging memberincludes a second threaded portion, wherein the first and secondthreaded portions cooperate with one another such that adjusting thecompression member tensions the engaging member to compress the firstand second bone portions with respect to one another.

According to some embodiments of the present invention, the stabilizingstructure is a compression plate.

According to some embodiments of the present invention, the stabilizingstructure is a periarticular plate.

According to some embodiments of the present invention, the insert snapsinto the first transverse aperture.

According to some embodiments of the present invention, the insert isintegral with the stabilizing structure.

According to another aspect of the present invention, there may beprovided a method for treating bone maladies including the steps of:associating a stabilizing structure with a first bone portion, thestabilizing structure including a first transverse aperture; engaging anengaging member with a second bone portion; at least partially insertingan insert through the first transverse aperture; the insert including asecond transverse aperture; and passing a compression member at leastpartially through the second transverse aperture; the compression memberat least indirectly interacting with the stabilizing structure; thecompression member contacting the second bone portion; the compressionmember contacting and interacting with the engaging member; and theengaging member at least partially extending through the secondtransverse aperture.

According to some embodiments of the present invention, a method fortreating bone maladies also includes using the compression member tofacilitate a sliding movement of the engaging member with respect to thestabilizing structure, the compression member at least indirectlyinteracting with the stabilizing structure to facilitate controlledmovement between the first and second bone portions.

According to some embodiments of the present invention, a method fortreating bone maladies also includes associating a guide with thestabilizing structure; and using the guide to guide the movement of atleast one bone preparation instrument.

According to some embodiments of the present invention, the guide isused to guide the movement of a plurality of bone preparationinstruments.

According to some embodiments of the present invention, the guide isused to guide the movement of the at least one bone preparationinstrument after the stabilizing structure has been associated with thefirst bone portion.

According to some embodiments of the present invention, the engagingmember is engaged with the second bone portion after the stabilizingstructure is associated with the first bone portion and after the guideis used to guide the movement of the at least one bone preparationinstrument.

According to some embodiments of the present invention, the insert is atleast partially inserted through the first transverse aperture after thestabilizing structure is associated with the first bone portion.

According to some embodiments of the present invention, using thecompression member to facilitate a sliding movement of the engagingmember facilitates compressing the second bone portion with respect tothe first bone portion.

‘Embodiment’ as used herein can be considered to mean an aspect orobject of the invention, and vice versa.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an intramedullary nail according to oneembodiment of the present invention shown installed in a femur.

FIG. 1A is a perspective view of an intramedullary nail according to oneembodiment of the present invention, shown in greater detail than theintramedullary nail shown in FIG. 1.

FIG. 1B is a perspective view of an intramedullary nail according toanother embodiment of the present invention.

FIG. 1C is a cross-sectional view of a portion of the nail of FIG. 1B.

FIG. 1D is a perspective view of an intramedullary nail according toanother embodiment of the present invention.

FIG. 2 is an elevation view of the intramedullary nail of FIG. 1.

FIG. 3 is a cross-section view of the intramedullary nail of FIG. 2taken through the line 3-3.

FIG. 4 is a side view of the intramedullary nail of FIG. 2.

FIG. 5 is a cross-section view of the intramedullary nail of FIG. 4taken through the line 5-5.

FIG. 6 is a cross-section of the intramedullary nail of FIG. 4 takenthrough the line 6-6.

FIG. 7 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 8 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 9 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 10 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 11 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 12 is a perspective view of an intramedullary nail according to analternative embodiment of the invention.

FIG. 13 is a cross-section view of the intramedullary nail of FIG. 7taken through line 13-13.

FIG. 14 is a cross-section view of the intramedullary nail of FIG. 8taken through line 14-14.

FIG. 15 is a cross-section view of the intramedullary nail of FIG. 9taken through line 15-15.

FIG. 16 is a cross-section view of the intramedullary nail of FIG. 10taken through line 16-16.

FIG. 17 is a cross-section view of the intramedullary nail of FIG. 11taken through line 17-17.

FIG. 18 is a cross-section view of the intramedullary nail of FIG. 12taken through line 18-18.

FIG. 19 is a perspective view of a tool according to an embodiment ofthe present invention for preparing bone to receive certain devicesaccording to certain embodiments of the present invention.

FIG. 20 is a perspective view of a device which includes a version of afastener assembly according to one embodiment of the present invention.

FIG. 21 is an exploded view of the intramedullary device and fastenerassembly shown in FIG. 20.

FIG. 22 is a perspective view of the fastener assembly shown in FIG. 20.

FIG. 23 is an exploded view of the fastener assembly of FIG. 20.

FIG. 24 is an elevation view of the engaging member of the fastenerassembly of FIG. 23.

FIG. 25 is a side view of the engaging member of FIG. 24.

FIG. 26 is a cross-section view of the engaging member of FIG. 24 takenthrough line 26-26.

FIG. 27 is an end view of one end of the engaging member of FIG. 24

FIG. 28 is an end view of the other end of the engaging member of FIG.24.

FIG. 29 is an elevation view of the compression device of the fastenerassembly of FIG. 22.

FIG. 30 is a cross-section view of the compression device of FIG. 29shown through line 30-30.

FIG. 31 is an end view of one end of the compression device of FIG. 29.

FIG. 32 is an end view of the other end of the compression device ofFIG. 29.

FIG. 33 is a cross-section view of an intramedullary nail and screwassembly according to another embodiment of the present invention.

FIG. 34 is a perspective view of a fastener assembly according toanother embodiment of the invention.

FIG. 35 is a perspective view of the lag screw of the fastener assemblyof FIG. 34.

FIG. 36 is a perspective view of a fastener assembly according toanother embodiment of the invention.

FIG. 37 is a perspective view of the lag screw of the fastener assemblyof FIG. 36.

FIG. 38 is a perspective view of a fastener assembly according toanother embodiment of the invention.

FIG. 39 is an exploded view of the fastener assembly of FIG. 38.

FIG. 40 is a perspective view of a fastener assembly according toanother embodiment of the invention.

FIG. 41 is an exploded view of the fastener assembly of FIG. 40.

FIG. 42 is a perspective view of a compression plate according to anembodiment of the present invention which includes a fastener assemblyaccording to an embodiment of the invention.

FIG. 43 is a perspective view of a periarticular plate according to anembodiment of the present invention which includes a fastener assemblyaccording to an embodiment of the invention.

FIG. 44 is a perspective view of a device according to an embodiment ofthe present invention used in the context of humeral repair in ashoulder joint.

FIG. 45 is a perspective view of a stabilizing structure according toanother embodiment of the present invention.

FIG. 46 is a perspective view of an insert that may be used inconjunction with the stabilizing structure shown in FIG. 45.

FIG. 47A is a side view of an apparatus for treating bone maladiesaccording to another embodiment of the present invention.

FIG. 47B is a side view of an apparatus for treating bone maladiesaccording to another embodiment of the present invention.

FIGS. 48-60 show various instruments and illustrate variousmethodologies that may, in some embodiments, be used to installapparatuses according to some embodiments of the present invention.

DETAILED DESCRIPTION OF DRAWINGS

Methods, devices and systems according to embodiments of this inventionmay seek to provide improved treatment of femur fractures and othertypes of bone maladies. FIGS. 1-6 illustrate various views of oneembodiment of an intramedullary nail 100 of the present invention. Theintramedullary nail 100 has a longitudinal bore 130 throughout to aid ininsertion in the bone. The intramedullary nail 100 has a proximalsection 102, a transition section 104 and a distal section 106.

In some embodiments, the proximal section 102 of the particularstructure shown in FIGS. 1-6 may feature an anatomically inspired shapethat corresponds more accurately to typical cortical bone. One versionof such shape is shown in the cross-sectional view of the proximalsection 102 in FIG. 6. The particular cross-section of the proximalsection 102 shown in FIG. 6 is generally non-circular along at leastsome portions of its length, and has a lateral side or aspect 108 thatis larger than a medial side or aspect 109. The lateral side 108 andmedial side 109 are joined by a first side 110 and a second side 116. Atthe intersection of the first side 110 with the lateral side 108 is afirst radiused corner 112 and at the intersection of the second side 116with the lateral side 108 is a second radiused corner 114. The firstside 110, second side 116 and lateral side 108 are of approximatelyequal length. The first side 110 and second side 116 are oriented atacute angles relative to the lateral side 108, so that the medial side109 is smaller than the lateral side 108. By having the lateral side 108larger than the medial side 109 the rotational stability of theintramedullary nail 100 is increased, and resistance to bending andtwisting can also be enhanced.

The medial side 109 shown in FIG. 6 can be radiused. As can be seen inFIG. 4, the radiused medial side 109 protrudes out from the transitionsection 104 and continues to the proximal end of the intramedullary nail100. The protrusion of the medial side 109 corresponds to the calcarregion of the femur and improves the evenness of load distributionbetween the bone and intramedullary nail 100.

Furthermore, the general cross-section geometry of the proximal sectionreduces peak stresses in the proximal section. More specifically, thetypical failure mode of an intramedullary nail and screw assemblycombination is failure of the nail in tension on its lateral side. Thetension is created by bending moment induced by body weight load that isapplied to the screw assembly. Therefore, it would be beneficial inreducing stress in the proximal section of a nail to include morematerial on the side of the nail that is in tension, the lateral side,to shape the cross section more effectively to enhance strength androbustness in the lateral area, or both. The design illustrated in FIG.6 accomplishes this. The lateral side 108 is wider than the medial side109, thus imparting, at least partially, a flange-like effect. Stressper unit area induced in the material on the lateral side 108 is lessthan would be the case if the lateral side was featured a smallercross-sectional area, such as medial side 109.

A structure according to another embodiment of the invention thatbenefits from the same principle is shown in FIGS. 1B and 1C, whichillustrate an intramedullary nail 1100 with a generally circular crosssection whose generally circular aperture 1128 is disposed other thanconcentric with the periphery of the cross section. In the particularstructure shown in these two Figures, the offset aperture 1128 is offsettoward the medial side 1109 such that a greater portion of material isavailable to take load, and reduce stress, on the lateral side 1108.Likewise, any cross-section that provides more material on the lateralside of the section reduces stress per unit area in the nail on thatside.

Regardless of the particular manner in which material or mass may beadded to some portions of the lateral parts of the cross section ofproximal portion 102, material may be added and removed from someportions of the cross section in order to increase the strength androbustness of the lateral parts, or both, the effect can becharacterized as imparting a moment of inertia to the cross sectionoriented at least partially in the direction of the lateral side oraspect 108. In some embodiments, the moment of inertia (shown denoted bythe letter M on FIG. 6) can be characterized as extending in a lateraldirection, or at least partially toward lateral aspect or side 108 froma point P that is the midpoint of a line L extending from theintersection I1 of that line with a tangent T1 to the lateral aspect108, to the intersection I2 of that line with a tangent T2 to the medialaspect 109. Stated another way, the effect in at least some cases is tocreate a cross section that features a moment of inertia extending in anat least partially lateral direction from a center of the cross section.Preferably, that center can be a midpoint between the lateral and medialedges of the cross section. Alternatively, that center can be the centerof mass of the cross section. The radius of gyration reflected by themoment of inertia, which is a function of the square of the distance ofthe incremental mass from the center, reflects additional strength inlateral parts of the proximal portion 102 caused by more mass or morestrategically placed mass in the cross section. In some structures, lineL is coplanar with the axis of the transverse aperture and coplanar withthe cross section and thus defined by the intersection of those planes.As FIGS. 1A on the one hand, and 1B and 1C on the other hand, reflect,and bearing in mind that these are only three of a myriad of structuresthat can impart such lateral additional strength and robustness, thecross section can but need not be asymmetrical with respect to at leastone of its axes. Additionally, the longitudinal opening 130 can belocated to share its central axis with that of the cross section, or itcan be offset in order to help impart the lateral strength or for otherpurposes.

In the particular devices shown in FIGS. 1, 1A, and 2-6, the first side110, second side 116 and lateral side 108 are flat. Alternatively, thesesides could be radiused or otherwise not flat. In the embodiments shownin FIGS. 1-6, the medial side 109 is radiused, but as one skilled in theart could appreciate, the medial side could be flat.

The proximal section 102 shown in FIG. 1A has a transverse aperture 118that receives a fastening or screw assembly 200 (various versions ofwhich are shown in FIGS. 20-41) through the intramedullary nail 100. Oneembodiment of the proximal transverse aperture 118, shown in FIGS. 1-4,is formed from two overlapping circular apertures 120, 122, where theproximal circle aperture 120 is smaller in diameter than the distalcircle aperture 122. The proximal circle aperture 120 shown has ashoulder 132 for constraining the insertion depth of the fasteningassembly as will be explained in more detail below. Various otherapertures allowing insertion of various fastening assemblies could beused as would be known to those skilled in the art. For example, FIG. 33illustrates the intramedullary nail with a circular aperture. Theembodiment of FIG. 33 is described in greater detail below.

The proximal section 102 illustrated in FIG. 3 has a proximal endaperture 128. The proximal end aperture 128 is threaded to allow for theinsertion of a set screw that can be used to fix the rotational andsliding position of a fastening assembly. A set screw may also includemechanisms for spanning a compression member 204 and interfering with anengaging member 204 to independently restrict the rotation or sliding ofthe engaging member 204.

As shown in FIGS. 1-6, the transition section 104 is tapered from theproximal section 102 to the distal section 106. The tapered nature ofthe transition section 104 creates a press fit in the intramedullarycanal that controls subsidence. The tapered transition section 104assists in preventing the nail 100 from being pressed further down intothe intramedullary canal of the femur than intended.

In the intramedullary nail 100 embodiments shown in FIGS. 1-6, thecross-section of the transition section 104 is circular, but thecross-section could vary as known to those skilled in the art. Thecross-section could be anatomically derived, similar to thecross-section of the proximal section 102, oval or non-circular. In theembodiment shown in FIGS. 1-6, the transition section 104 contains adistal transverse aperture 124. The distal aperture 124 allows theinsertion through the intramedullary nail 100 of a distal locking screwfor locking of the intramedullary nail 100.

The distal section 106 of the intramedullary nail 100 is generallycylindrical and is configured to provide a reduced bending stiffness.The embodiments shown in FIGS. 1-5 include a longitudinal slot 126through the center of the distal section 106 that forms two sides 134,136. The slot reduces bending stiffness at the distal end of theintramedullary nail 100 and reduces the chances of periprostheticfractures.

FIG. 1D shows an intramedullary nail 100 according to another embodimentof the invention. This nail features, in its proximal portions, anoncircular cross section that is symmetrical with respect to itslateral—medial axis (in this case, preferably but not necessarily, ovalshaped in cross-section), and which features a centered longitudinalbore (in this case, preferably but not necessarily, circular incross-section). This nail achieves additional stability to the extent itresists twisting in the medullary canal. It also accomplishes the aim ofplacing more mass toward the lateral edge or aspect of the proximalcross section. Furthermore, it places additional mass toward the medialedge or aspect, and thus provides additional structure that acts as afulcrum to decrease the mechanical advantage of the fastening assemblywhich when loaded is the component that imposes tensional stress on thelateral edge or aspect.

FIGS. 7-18 illustrate intramedullary nails 100 according to otherembodiments of the invention. FIG. 7 illustrates an intramedullary nail100 having no longitudinal bore throughout.

FIGS. 8 and 14 illustrate an intramedullary nail 100 having stiffnessreduction slots 140 in the transition section 104 and the distal section106. The stiffness reduction slots 140 reduce the bending stiffness atthe distal end of the intramedullary nail 100 and could be used toreceive locking screws in some embodiments.

FIGS. 9 and 15 illustrate an intramedullary nail 100 having threelongitudinal slots 138 in the distal section 106 and a portion of thetransition section 104 forming a cloverleaf pattern. This pattern morereadily permits blood flow near the intramedullary nail 100 and alsoreduces bending stiffness at the distal end of the nail 100.

FIGS. 10 and 16 illustrate an intramedullary nail 100 in which thedistal section 106 and a portion of the transition section 104 have aseries of longitudinal grooves 146. The longitudinal grooves 146 reducebending stiffness at the distal end, provide rotational resistance, andenhance blood flow near the intramedullary nail 100.

FIGS. 11 and 17 illustrate an intramedullary nail 100 where thetransition section 104 and the distal section 106 have fins 144. Thefins 144 provide rotational resistance for the intramedullary nail 100.

FIGS. 12 and 18 illustrate an intramedullary nail 100 having barbs 142located on the distal section 106 and a portion of the transitionsection 104. The barbs 142 provide rotational resistance for theintramedullary nail 100.

Intramedullary nails according to some embodiments of the presentinvention may be inserted into a patient by any suitable knowntechnique. Generally, the intramedullary canal of the bone is preparedwith an appropriate tool to create a void for insertion of the nail.Some portions of the void may be prepared to be about 1 millimeterlarger than the perimeter of the nail to permit sufficient space forblood flow after insertion of the nail. A guide pin or wire isoptionally inserted into the prepared medullary canal. The nail is thenintroduced into the desired position. If the nail is cannulated, thenail can be introduced over the guide wire. The position of the nail maybe confirmed by image intensification.

FIG. 19 shows one embodiment of a tool 300 for preparing a medullarycanal. The tool has a drill bit 302 for reaming and also a mortisechisel 304. In operation, the drill bit 302 reams out the medullarycanal of the femur and the mortise chisel 304 cuts out a larger sectionin the more proximal end of a bone. As shown in FIG. 19, the mortisechisel 304 has an anatomically derived cross-section of approximatelythe same shape as the proximal section of the intramedullary nail. Byapplying this type of shaped, mortise chisel, the proximal end of thenail will be better enabled to seat on cortical bone that has been onlyminimally altered. The mortise chisel 304 may be of a wide variety ofshapes, even complicated, asymmetrical shapes. This is advantageousbecause it enables a device and method for preparing voids able toaccept a wide variety of shapes of intramedullary nails without merelyover-reaming circular voids. Preparation of an accurately conformingvoid is valuable in avoiding unnecessary removal of healthy bone, and inensuring stable seating of the nail.

In operation, the tool 300 of the embodiment shown is advanced as aunit, with the drill bit 302 reaming and the mortise chisel 304 cuttingsimultaneously. The drill bit 302 may be turned with a power driver, orby hand. Likewise, the entire tool 300 may be advanced into a medullarycanal manually, or advanced with the assistance of mechanical advantageor power equipment. In other configurations, the drill bit 302 may becannulated (not shown) such that the entire tool 300 is operable overand guided by a guide wire that has been inserted into the medullarycanal.

In other embodiments, the bit for reaming is a more traditional reamerthat is separate from a cutting tool such as the mortise chisel 304. Themethod for preparing a void in such an instance would include firstreaming an opening with a traditional reamer. A device such as a chiselor a broach, shaped similar to the intramedullary nail to be implanted,would then be used to prepare the void. The chisel or broach may bedriven in by hand, with the assistance of a hammer or mallet, or withthe use of other power equipment. A nail consistent with the voidprepared would then be implanted.

Other custom instruments such as a contoured broach or a custom routerbit and template could be used as well. Broaches have long been used toprepare openings for hip stems, and the use of a broach would befamiliar to one of skill in the art. A router bit and template could beuse, in effect, to mill out the desired shape in the bone. Such a methodmight also be used in combination with reaming or broaching to createthe desired void.

Intramedullary nails in accordance with some of the embodiments of thepresent invention may be used to treat proximal femoral fractures andfemoral shaft fractures, among other fractures of long bones and otherbone maladies. When used to treat femoral shaft fractures, theintramedullary nail is secured in the femur by one or more fasteningdevices. When used for the treatment of proximal femoral fractures theintramedullary nail is preferably used in conjunction with a fasteningassembly.

FIGS. 20 and 21 illustrate an intramedullary nail 100 according to oneembodiment of the present invention used in conjunction with a fasteningassembly 200 according to one embodiment of the present invention. Thistype of fastening assembly may be used in a variety of bones and totreat a number of indications, but for the purpose of providing anexample, it is being described here in use with the proximal femur. Ingeneral, the fastening assembly is useful in any situation where onefragment of a bone is to be drawn back toward or pushed away fromanother fragment of the bone in a controlled manner. The fasteningassembly provides the additional advantage of being configurable toallow sliding of the assembly in a desired direction after the movementof the bone fragments has been accomplished.

As shown in FIG. 21, the axis of the proximal transverse aperture 118 inthe intramedullary nail 100 is angled relative to the proximal section102 and in use, is directed towards the femoral head. In this embodimentof the fastener assembly 200, an engaging member such as a lag screw 202is used in conjunction with a compression member, such as a compressionscrew 204 or a compression peg. The screws are configured such that whenin use the circumference of the lag screw 202 partially intersects withthe circumference of the compression screw 204, so that the compressionscrew 204 nests partially within the circumference of the lag screw 202.This particular combination of lag screw 202 and compression screw 204are further illustrated in FIGS. 22 through 32. Briefly, the lag screw202 shown in these figures is intended to engage the femoral head and toslide in the transverse aperture 118 of the nail 100. The compressionscrew 204 engages a shoulder or other structure in transverse aperture118 and also threads in the portion of lag screw 202 within whichcompression screw 204 nests, so that rotation of compression screw 204controls sliding of the lag screw 202 relative to the nail 100 and thuscompression of the femoral head against the fracture site.

The lag screw 202 shown in these drawings includes an elongate body 206and threaded end 208. As shown in FIGS. 24 and 25, the threaded end 208does not include a sharp end, which reduces the possibility of cut outthrough the femoral head. The elongate body 206 includes a channel 212that allows for the positioning of the compression screw 204 partiallyinside the circumference of the lag screw 202. The channel 212 includesa threaded portion 210 that compliments and cooperates with a threadedsection 214 of the compression screw 204. The compression screw 204includes a threaded section 214 and a head section 215. The threadedsection 214 of the compression screw 204 is configured such that thethreads are relatively flat and smooth at the exterior surface so thatthey can easily slide in the aperture and also reduce the possibility ofcut out.

The lag screw 202 is received in the proximal transverse aperture 118and into a pre-drilled hole in the femur so that the lag screw 202extends across the break and into the femoral head. The threaded end 208of the lag screw 202 engages the femoral head as the lag screw 202 isrotated within aperture 118, causing its threaded end 208 to engage thefemoral head. The threaded end 208 may be any device for obtainingpurchase in the femoral head, and includes, but is not limited to,threads of any desired configuration including helices, barbs, blades,hooks, expanding devices, and the like. The placement depth of the lagscrew 202 into the femoral head differs depending on the desiredcompression of the fracture.

The compression screw 204 can also be received through the proximaltransverse aperture 118 into a predrilled hole in the femoral head. Thethreaded section 214 of the compression screw 204 engages with thethreaded portion of the channel 212 of the lag screw 202. The proximaltransverse aperture 118 has an interior shoulder 132 (FIG. 21) to limitthe sliding of the compression screw 204 in the general medial directionand, therefore, the lag screw 202, through the aperture 118. When thecompression screw 204 is tightened, the compression screw threads 214engage with the lag screw channel threaded portion 210 and thecompression screw 204 moves in the generally medial direction down thelag screw 202. The head section 215 of the compression screw 204 engagesthe shoulder 132 of the proximal transverse aperture 118 preventing thecompression screw 204 from moving further in the general medialdirection. As the compression screw 204 is tightened, the lag screw 202is drawn in the general lateral direction toward the intramedullary nailcompressing the fracture. The compression screw 204 partiallyintersecting the circumference of the lag screw 202 provides greatersurface resistance and aids in the prevention of femoral head rotation.The compression screw 204 therefore acts not only as a part of themechanism for moving fragments of the fractured bone relative to oneanother, but also directly contacts bone of the femoral head to helpprevent the femoral head from rotating about the axis of the lag screw202. In other embodiments, it is not necessary to use the compressionscrew 204 (which may also be referred to as a compression member asdiscussed below) to compress the fracture, and the fracture may bestabilized simply by installing the compression screw 204 and lag screw202 (which may also be referred to as an engagement member as discussedbelow).

In one embodiment, a set screw (not shown), positioned in the proximalend aperture 128 of the intramedullary nail, is used to engage thecompression screw 204 and fix the compression screw 204 and lag screw202 in place. The use of the set screw to fix the fastener assembly 200in place may be fracture pattern dependent. If a set screw is not usedto engage the fastener assembly, the fastener assembly 200 can slidewithin the proximal aperture limited by the shoulder 132.

In the embodiment of the lag screw and compression screw shown in FIGS.20-32, the diameter of the compression screw 204 is smaller than thediameter of the lag screw 202. In other embodiments, the diameters ofthe lag screw and compression screw could be the same or the diameter ofthe lag screw could be smaller than the diameter of the compressionscrew. The threads of the lag screw and the compression screw could be avariety of different shapes as known to those skilled in the art. Ingeneral, the purpose of the lag screw is to obtain purchase in bone, andthe purpose of the compression screw is to engage with and draw or movethe lag screw. Any configuration that permits these functions is withinthe scope of the invention.

The fastener assembly 200 shown in the Figures could additionally beconfigured to allow the addition of a prosthetic femoral head and neck.In such an embodiment, the lag screw 202 would be replaced with aprosthetic head and neck. The neck would fit into the proximaltransverse aperture 118 in the nail 100. The design would be beneficialwhere degeneration or re-injury of a repaired femoral fracture and hipjoint later necessitated a total hip arthroplasty (THA). The decision toaccomplish a THA could be made interoperatively, or after some period oftime. Instead of having to prepare a femur to accept a hip stem as isknown in association with THA, only a small portion of bone would needto be removed, along with the fastener assembly 200. The prosthetic headand neck could then be inserted into the proximal transverse aperture118, the acetabulum prepared, and the remainder of the THA completed.

FIG. 33 is a cross-section view of an intramedullary nail 100 accordingto another embodiment of the invention with an alternate fastenerassembly 400. The fastener assembly illustrated is very similar to thecompressing fastener assembly of Smith & Nephew's IMHS® system, as ismore thoroughly disclosed in U.S. Pat. No. 5,032,125 and various relatedinternational patents. The improvement of the device illustrated is thatit includes the intramedullary nail 100 with an anatomically derivedshape and its multiple advantages as discussed above. In operation, asleeve 401 fits through the intramedullary nail 100, and may be securedto the nail by set screw, or other effective mechanisms. A sliding lagscrew 402 is able to move axially within the sleeve 401. A compressingscrew 404 is threaded into the sliding lag screw 402 such thattightening of the compressing screw 404 draws the sliding lag screw 402back into the sleeve 401. With this mechanism, a bone fragment may bebrought into a desired position, but still permitted to achieve slidingcompression once positioned.

FIGS. 34-35 illustrate a fastener assembly 200 according to anotherembodiment of the invention having a lag screw 202 and a compression peg502. As shown in FIG. 34, the lag screw 202 and the compression peg 502are configured such that, when in use, the circumference of the lagscrew 202 partially intersects with the circumference of the compressionpeg 502, although in some embodiments the circumferences might beadjacent rather than intersecting. The lag screw 202 includes anelongate body 206 and threaded end 208. The lag screw 202 has a key 504on the channel 212. The compression peg 502 has a slot 503 that isadapted to receive the key 504 of the lag screw 202. The key 504 andslot 503 can be a variety of complimentary shapes, such as, whenconsidered in cross section, triangular, D-shaped, key-holed and othershapes as are apparent to those skilled in the art. In operation, thecompression peg 502 may be moved relative to the lag screw 202 by acompression tool (not shown) that applies disparate forces between thecompression peg 502 and the lag screw 202, or between the entireassembly and the intramedullary nail 100.

In the fastener assembly 200 shown in FIGS. 34-35, the lag screw 202 isreceived to slide in a proximal aperture of the intramedullary nail sothat the lag screw 202 extends across the break and into the femoralhead. The threaded end 208 of the lag screw 202 engages the femoralhead. Once the lag screw 200 has been properly engaged with the femoralhead, the compression peg 502 is inserted in the proximal aperture intoa predrilled hole in the femoral head, in order to prevent furtherrotation of the lag screw 202 as the slot 503 of the compression peg 502receives the key 504 of the lag screw 202. By providing more area forresistance, the compression peg 502 helps to prevent the rotation of thefemoral head on the lag screw 202. The compression peg 502 is fixed inposition in the intramedullary nail 100 by a set screw positioned in theproximal end aperture of the nail. The lag screw 202 can slide on thecompression peg 502 through the proximal aperture. In anotherembodiment, the compression peg 502 has barbs on its surface.

A fastener assembly 200 according to another embodiment of the inventionis illustrated in FIGS. 36-37. The fastener assembly 200 of thisembodiment has a compression peg 502 and a lag screw 202 similar to theembodiment illustrated in FIGS. 34-35, except that the key 504 of thelag screw 202 and the slot 503 of the compression peg 502 havecomplimentary ratchet teeth 506. The compression peg 502 is fixed inposition in the intramedullary nail by a set screw positioned in theproximal end aperture. Compression of the fracture can be achieved bypulling the lag screw in the general lateral direction. The ratchetteeth 506 allow the lag screw 202 to move in the general lateraldirection, but prevent the lag screw 202 from moving in the generalmedial direction. A compression tool similar to the tool described inassociation with FIGS. 34-35 may be used to accomplish the movement.

FIGS. 38-39 show a fastener assembly 200 according to another embodimentof the invention having a lag screw 602, a cross hair screw 610 and acompression screw 604. The lag screw 602 includes an elongate body 606and threaded end 608. The elongate body 606 is semi-circular shaped incross section. The screws 602, 604, 610 are configured so that thecircumference of the lag screw 602 intersects with the circumferences ofthe cross hair screw 610 and the compression screw 604. The elongatebody 606 of the lag screw 602 is threaded to compliment and cooperatewith a threaded section 602 of the cross hair screw 610. The cross hairscrew 610 is threaded to engage with the lag screw 602 and thecompression screw 604. The compression screw 604 includes a threadedportion 614 and a head portion 612.

In this embodiment, the lag screw 602, the cross hair screw 610 and thecompression screw 604 are received simultaneously to slide in a proximalaperture of an intramedullary screw. The lag screw 602 extends acrossthe break and into the femoral head. The threaded end 608 of the lagscrew 602 engages the femoral head. As compression screw 604 istightened, the threads 614 of the compression screw engage the threadsof the cross hair screw 610 and lag screw 602, thereby moving the lagscrew 602 in the general lateral direction toward the intramedullarynail providing compression to the femoral head. The cross hair screw 610is then turned causing the compression screw 604 to move in the distaldirection away from the lag screw 602. The fastener assembly 200 canalternatively be configured so that the compression screw 604 movesproximally relative to the lag screw 602. The compression screw 604separates from the lag screw 602 to help to prevent rotation of thefemoral head on the lag screw 602 by adding more area for resistance.

FIGS. 40-41 illustrate a fastener assembly 200 according to anotherembodiment of the invention having a lag screw 702 and a compression peg704. The lag screw 702 includes an elongate body 706 and a threaded end708. The elongate body 706 is semi-circular shaped in order to allow thecompression peg 704 to be positioned partially inside the circumferenceof the lag screw 702 for insertion into the femur and has a key 712positioned on the interior side of the elongate body 706. The elongatebody 706 also has an aperture 710 through the body. The compression peg704 is generally cylindrical and is sized to fit within thesemi-circular body 706 of the lag screw. The key 712 of the lag screw isreceived by a slot 714 in the compression peg 704. The key 712 and slot714 contain complimentary ratchet teeth (not shown).

In this embodiment, the lag screw 702 and the compression peg 704 arereceived simultaneously to slide in a proximal aperture of anintramedullary nail into a pre-drilled hole in the femur. The lag screw702 extends across the break and into the femoral head. The threaded endof the lag screw 702 engages the femoral head. A compression toolsimilar to the tool describe in association with FIGS. 34-35 may be usedto accomplish movement between the compression peg 704 and the lag screw702, or between the entire assembly and the intramedullary nail 100. Aset screw may used to fix the position of the fastener assembly. The setscrew is configured such that when the set screw is tightened aprotrusion on the set screw is received through the slot 710 of the lagscrew 702 and moves the compression screw 704 away from the lag screw702. The compression screw 704 separate from the lag screw 702 helps toprevent rotation of the femoral head on the lag screw by adding morearea for resistance.

FIG. 42 illustrates another embodiment of the invention where a fastenerassembly 200 is employed in cooperation with a compression plate 150. Asillustrated, the devices are being applied to a femur. The variousembodiments of the fastener assembly 200 disclosed above may be usedwith a similar compression plate, and various compression plates may beconfigured to be applicable to other parts of the anatomy.

FIG. 43 illustrates another embodiment of the invention where a fastenerassembly 200 is being used with a periarticular plate 170. The plate andfastener assembly shown are being applied to a proximal tibia. Thevarious embodiments of the fastener assembly 200 disclosed above may beused with a similar periarticular plate and various periarticular platesmay be configured to be applicable to other parts of the anatomy.

FIG. 44 illustrates another embodiment of the invention where a fastenerassembly 200 is used in combination with a humeral nail 190. Asillustrated, a head section 212 of compression screw 204 bears againstthe humerus to draw compression against the humerus. With thecompression force applied to lag screw 202, and the lag screw 202affixed to a bone fragment through its threaded end 208, the bonefragment may be drawn into position for proper healing. In somecircumstances, it may be advantageous to place a washer or bearingsurface (not shown) between the head section 212 and the humeral boneagainst which the head section 212 compresses. In yet another variant,the opening in the humerus may be enlarged such that head section 212 ispermitted to penetrate the humerus and bear against a portion of thehumeral nail 190. In such an embodiment, the fastener assembly 200 wouldbe shorter than illustrated in FIG. 45 to obtain purchase in the samearea of bone with the threaded end 208. The various embodiments of thefastener assembly 200 disclosed above may be used with a similar nailand various nails may be configured to be applicable to other parts ofthe anatomy.

FIGS. 45-60 show apparatuses 2000 for treating bone maladies inaccordance with other embodiments of the present invention. Theapparatuses 2000 shown in these figures generally include a stabilizingstructure 2002 and a fastening assembly 2004. The stabilizing structure2002 shown in FIG. 45 is a bone plate, however, in other embodiments,stabilizing structure 2002 may be other orthopaedic devices for at leastpartial application to the bony anatomy, such as the outer surface of abone.

Similar to the intramedullary nails discussed above, the stabilizingstructure 2002 may feature geometries that impart a moment of inertia toa cross section of the stabilizing structure 2002 oriented at leastpartially in the direction of a lateral side or aspect of thestabilizing structure 2002, to increase its strength and/or robustness.For instance, FIG. 45 shows a stabilizing structure 2002 in which theproximal portion has a lateral side with an increased mass to impartadditional strength and resistance to tension. In other embodiments,however, such geometries are unnecessary and stabilizing structure 2002may feature other traditional or non-traditional geometries.

The stabilizing structure 2002 shown in FIG. 45 includes a firsttransverse aperture 2006 and a number of additional apertures 2008.Transverse aperture 2006 extends through a proximal portion ofstabilizing structure 2002, such that it can receive a fasteningassembly 2004 and (optionally) an insert 2010, as discussed furtherbelow. The transverse aperture 2006 shown in FIG. 45 extends throughstabilizing structure 2002 at an angle, such that fastening assembly2004 will roughly parallel a longitudinal axis of the femoral neck whenthe stabilizing structure 2002 is applied to the proximal femur in themanner shown in FIGS. 47A and 47B. In other embodiments, however,apparatus 2000 can be used to treat bone maladies associated with otherparts of the bony anatomy, and transverse aperture 2006 does notnecessarily extend through stabilizing structure 2002 at an angle.

The additional apertures 2008 shown in FIG. 45 may be used inconjunction with bone screws or other types of fastening or anchoringdevices to secure the stabilizing structure 2002 to the bony anatomy. Asdiscussed further below, one or more of the additional apertures 2008may also be used to associate the stabilizing structure 2002 withvarious instrumentation used to install the apparatus 2000.

The transverse aperture 2006 of the stabilizing structures 2002 shown inFIG. 45 may receive an insert 2010 that includes a second transverseaperture 2012, through which the fastening assembly 2004 may pass. Onetype of insert 2010 is shown in FIG. 46 and includes an arm 2014 and aridge member 2016 that can interact with indentions/grooves 2018 and2020 in stabilizing structure 2002 to allow the insert 2010 to besecurely snapped into the transverse aperture 2006 in stabilizingstructure 2002. In other embodiments, the arm 2014 and ridge member 2016can extend from stabilizing structure 2002 and the indentions 2018 and2020 can be located in insert 2010. In some embodiments, ridge member2016 may be a clip engaged with two apertures extending at leastpartially into insert 2010, as shown in FIG. 46. In still otherembodiments, other structures, devices, and mechanisms can be used toassociate insert 2010 with stabilizing structure 2002.

The insert 2010 shown in FIG. 46 also includes a flange 2022 that caninteract with one or more portions of the fastening assembly 2004 in asomewhat similar manner to the shoulder 132 discussed in conjunctionwith the intramedullary nails described above.

The second transverse aperture 2012 shown in FIG. 46 is formed from twooverlapping circular apertures, where the distal circular aperture issmaller in diameter than the proximal aperture. In other embodiments,the proximal aperture's diameter may be smaller than the distalaperture's diameter, the apertures may have the same diameter, or theapertures may be formed in other, such as non-circular, shapes.

In some embodiments, the use of a modular insert, such as the insert2010 shown in FIG. 46, may allow the apparatus 2000 to be installed intoa patient using minimally or less invasive techniques, such as, but notlimited to, the techniques described further below. For instance, insome embodiments, the use of stabilizing structure 2002 in conjunctionwith a modular insert 2010, where the stabilizing structure 2002 isinstalled first and the modular insert 2010 is installed later, mayreduce the size of the incision necessary for installation of theapparatus 2000, as opposed to devices that include a one piece structurein the place of the stabilizing structure 2002 and insert 2010.

In these or other embodiments, use of a modular insert 2010 inconjunction with stabilizing structure 2002 may also facilitate a moreaccurate installation of apparatus 2000. For instance, in someembodiments, stabilizing structure 2002 may be installed prior tocertain bone preparation operations, such as drilling cavities necessaryfor receiving fastening assembly 2004 and/or insert 2010. In suchembodiments, the stabilizing structure 2002 may be used to reference andlocate various bone preparation operations to facilitate drillingcavities and performing other bone preparation operations accuratelywith respect to the already installed stabilizing structure 2002.

The fastening assembly 2004 used in conjunction with apparatus 2000shown in FIGS. 45-61 includes an engaging member 2024 and a compressionmember 2026. The engaging member 2024 may be positioned above thecompression member 2026 (shown in FIG. 47A), below the compressionmember 2026 (shown in FIG. 47B), or in some other arrangement. Engagingmember 2024 can be used to engage a second bone portion, such as thefemoral head shown in FIG. 47A. The compression member 2026 may contactand interact with the engaging member 2024 to facilitate a slidingmovement of the engaging member 2024 with respect to the transverseapertures 2006 and/or 2012. The compression member 2026 may also atleast indirectly interact with the stabilizing structure 2002 tofacilitate controlled movement between the bone portions. When apparatus2000 is used in conjunction with an insert 2010, engaging member 2024may slide with respect to transverse aperture 2012 (the sliding of whichmay be controlled by compression member 2026) and a shoulder ofcompression member 2026 may interact with flange 2022 to limit the depthof insertion of the fastening assembly 2004.

The fastening assembly used in conjunction with stabilizing structure2002 may be any of the fastening assemblies illustrated in any of theFigures herein, or may be other types of fastening assemblies, and mayfunction and be used in similar manners as the fastening assembliesdescribed above in conjunction with intramedullary nails.

FIGS. 48-60 illustrate instrumentation used in accordance with onemethod for installing the apparatus 2000 shown in FIG. 47A, althoughother methods are possible and within the scope of the presentinvention.

FIG. 48 shows the stabilizing structure 2002 associated with a handle2030. The handle 2030 can be attached to the stabilizing structure 2002using a locking post screw 2032 connected to one of the apertures 2008(such as shown in FIG. 48) or in another manner. Using the handle 2030,the stabilizing structure 2002 may be inserted percutaneously, keepingsoft tissue damage to a minimum. Once inserted percutaneously,stabilizing structure 2002 may be secured to an outer surface of thebony anatomy using one or more screws or other fasteners passing throughapertures 2008. In other embodiments, stabilizing structure 2002 can besecured to the bony anatomy using screws or other fasteners passingthrough apertures 2008 at any point during the installation of apparatus2000.

As shown in FIG. 49, the handle 2030 may also receive a targeter 2034.The targeter 2034 shown in FIG. 49 includes an opening 2036 to permitthe insertion of a drill sleeve 2038 (as shown in FIG. 50) as well asother apertures 2040 for receiving additional fixation tools, devices orother structures. In other embodiments, targeter 2034 is integral withhandle 2030. In still other embodiments, targeter 2034 is not necessary,and drill sleeve 2038 may be positioned with respect to the stabilizingstructure 2002 in another manner. For instance, in some embodiments,drill sleeve 2038 is connected to handle 2030 directly, or is formedintegrally with handle 2030.

The drill sleeve 2038 shown in FIG. 50 extends through the opening 2036in the targeter 2034 to approximately the transverse aperture 2006extending through stabilizing structure 2002. As shown, the drill sleeve2038 includes first and second tubular portions 2042 and 2044. Tubularportions 2042 and 2044 may receive a wide variety of tools, instruments,and other items.

For instance, FIGS. 51 and 52 illustrate the insertion of a guide pinsleeve 2046 into the first tubular portion 2042, which may be cannulatedto receive a guide pin (not shown). The guide pin may be used to guidethe movement of subsequent instrumentation or other items placed intoone or both of the tubular portions 2042 and 2044.

FIGS. 53-54 illustrate the insertion of a compression member drill guide2048 into the second tubular portion 2044 to guide the movement of oneor more drills that will prepare a cavity in the bone for receiving thecompression member 2026. Similar instrumentation may be used to prepareanother (albeit overlapping in some embodiments) cavity for receivingthe engaging member 2024. The same, or different, instrumentation may beused to prepare portions of the drilled cavities to receive the insert2010 as well. For instance, in some embodiments, there may be fourdrilling procedures: one to drill a cavity for receiving the compressionmember 2026, a second to drill a proximal portion of that cavityslightly larger to receive, in part, the insert 2010, a third to drill acavity for receiving the engaging member 2024, and a fourth to drill aproximal portion of that cavity slightly larger to receive, in part, theother part of the insert 2010 not accounted for by the second drillingoperation. The order and number of these drilling procedures are notnecessarily important in all embodiments. In some embodiments, it may bedesirable to insert an anti-rotation device 2050 (such as shown in FIG.55) into one or both of the tubular portions 2042 and 2044 to preventthe bone portions from rotating with respect to one another during thedrilling procedures.

After the cavity for the engaging member 2024 has been prepared, theengaging member 2024 may be inserted using an inserter, such as theinserter 2052 shown in FIG. 56. The inserter 2052 shown in FIG. 56includes a long cylindrical body 2054 attached to a T-handle 2056. Theinserter 2052 may be used to drive the engaging member 2024 into theprepared cavity, and also to rotate the engaging member 2024 tofacilitate engaging the bone, such as the femoral head. In someembodiments, the inserter 2052 may be cannulated and include a rodextending along at least a portion of the length of the cannulation,with a threaded tip at its end. This threaded tip may interact withthreads (not shown) inside the head of the engaging member 2024 toconnect the inserter 2052 to the engaging member 2024. In otherembodiments, power tools may be employed to help engage the engagingmember 2024 with the bone.

After the engaging member 2024 is installed, as shown in FIGS. 57-60,the T-handle 2056 may be removed and the insert 2010 may be slipped overthe cylindrical body 2054 of the inserter 2052 and driven into placeusing another inserter 2058. The instrumentation may guide the insert2010 over the engaging member 2024 and into the transverse aperture 2006of the stabilizing structure 2002. The ridge 2016, arm 2014 andindentations 2018 and 2020 discussed above may allow the insert to besnapped into place in the transverse aperture 2006.

Subsequently, the compression member 2026 may be installed and adjusted.(as discussed above for the intramedullary nail, or in other manners)and the various instrumentation may be removed to complete theinstallation.

In accordance with the above-described, or other, methodologies, anapparatus 2000 may be installed in the following manner. First, one ormore incisions may be made into the patient proximal the relevant bonyanatomy. Next, the handle 2030 (as assembled to stabilizing structure2002, as shown in FIG. 48) may be used to position stabilizing structure2002 proximate the relevant bony anatomy, such as the lateral side ofthe proximal femur. Next, the targeter 2034 may be assembled to thehandle 2030 as shown in FIG. 49, although, in other embodiments,targeter 2034 may already have been assembled to handle 2030, or may noteven be necessary. Subsequently, the drill sleeve 2038 may be insertedthrough targeter opening 2036 (although in other embodiments, drillsleeve 2038 may be associated directly with handle 2030 or may beassociated with stabilizing structure 2002 in some other manner), asshown in FIG. 50.

As shown in FIGS. 51 and 52, a guide pin sleeve 2046 may be insertedinto first tubular portion 2042. Next, a guide pin or wire may beinserted through a longitudinally extending aperture in guide pin sleeve2046, and the guide pin or wire may engage a portion of the bonyanatomy. In some embodiments, the axis of the guide pin may define theaxis of the engaging member 2024, once the engaging member 2024 isinstalled. At this point, in some embodiments, fasteners may beinstalled through additional apertures 2008 to secure the stabilizingstructure 2002 to the bony anatomy, although, in other embodiments,these fasteners may be installed at other points during theinstallation.

FIG. 53 shows the compression member drill guide 2048 being insertedinto the second tubular portion 2044 of the drill sleeve 2038 next. Anaperture extending through the compression member drill guide 2048 mayreceive a drill bit for preparing the bony anatomy to receive thecompression member 2026. Subsequently, the compression member drillguide 2048 may be removed and a second drill bit may be guided throughsecond tubular portion 2044 to prepare the bony anatomy to receive aportion of an insert 2010. In other embodiments, both of these drillingoperations may be accomplished using a single combination drill bit,such as a bit similar to the combination drill bit described below. Asshown in FIG. 55, an anti-rotation device 2050 may be subsequentlyinserted into second tubular portion 2044 such that a distal portion ofthe device 2050 fits into the portion of the bony anatomy prepared forthe compression member 2026 and a proximal portion of the device 2050fits into the portion of the bony anatomy prepared to receive a portionof the insert 2010.

Subsequently, the guide pin sleeve 2046 may be removed and one or moredrill bits may be guided over the guide pin or wire through the firsttubular portion 2042 to prepare the bony anatomy to receive the engagingmember 2024 and other portions of the insert 2010. In some embodiments,this step may be accomplished using a combination drill bit thatincludes two different outer diameters. In other embodiments, multipledrill bits may be employed.

Next, the inserter 2052 shown in FIG. 56 may be used to install theengaging member 2024 and insert 2010, as described above and shown inFIGS. 56 through 60. Subsequently, the compression member 2026 may beinstalled. In some embodiments, the compression member 2026 maysubsequently be used to compress the fracture, although in otherembodiments, it may not be necessary or desirable to compress thefracture.

As those skilled in the art will appreciate, the particular embodimentsof this invention described above and illustrated in the figures areprovided for explaining the invention, and various alterations may bemade in the structure and materials of the illustrated embodimentswithout departing from the spirit and scope of the invention asdescribed above and in the following claims.

1. Apparatus for treating bone maladies, comprising: (a) a stabilizingstructure associated with a first bone portion, the stabilizingstructure comprising a first transverse aperture; and (b) a fasteningassembly at least partially extending through the first transverseaperture, the fastening assembly comprising an engaging member and acompression member: (i) wherein the engaging member engages a secondbone portion; (ii) wherein the compression member contacts and interactswith the engaging member; (iii) wherein the compression member contactsthe second bone portion; and (iv) wherein the compression member atleast indirectly interacts with the stabilizing structure.
 2. Theapparatus for treating bone maladies of claim 1, further comprising aninsert at least partially extending through the first transverseaperture and comprising a second transverse aperture; wherein thefastening assembly at least partially extends through the secondtransverse aperture.
 3. The apparatus for treating bone maladies ofclaim 2, wherein the compression member facilitates a sliding movementof the engaging member with respect to the first transverse aperture;and wherein the compression member facilitates a controlled movementbetween the first and second bone portions.
 4. The apparatus fortreating bone maladies of claim 2, wherein the compression member atleast indirectly interacts with the insert to facilitate controlledmovement between the first and second bone portions.
 5. The apparatusfor treating bone maladies of claim 4, wherein the compression membercomprises a shoulder that abuts against a portion of the insert.
 6. Theapparatus for treating bone maladies of claim 2, wherein the controlledmovement between the first and second bone portions comprisessubstantial preclusion of rotation of the first and second bone portionswith respect to one another.
 7. The apparatus for treating bone maladiesof claim 2, wherein the controlled movement between the first and secondbone portions comprises compressing the first and second bone portionswith respect to one another.
 8. The apparatus for treating bone maladiesof claim 7, wherein adjusting the compression member tensions theengaging member to compress the first and second bone portions withrespect to one another.
 9. The apparatus for treating bone maladies ofclaim 2, wherein the compression member is at least partially nestedwithin a portion of the engaging member.
 10. The apparatus for treatingbone maladies of claim 9, wherein the compression member comprises afirst threaded portion and the engaging member comprises a secondthreaded portion; wherein the first and second threaded portionscooperate with one another such that adjusting the compression membertensions the engaging member to compress the first and second boneportions with respect to one another.
 11. The apparatus for treatingbone maladies of claim 2, wherein the insert snaps into the firsttransverse aperture.
 12. The apparatus for treating bone maladies ofclaim 11, wherein an arm interacts with an indention to facilitate theinsert snapping into the first transverse aperture.
 13. The apparatusfor treating bone maladies of claim 11, wherein a ridge member interactswith an indention to facilitate the insert snapping into the firsttransverse aperture.
 14. Apparatus for treating bone maladies,comprising: (a) a stabilizing structure associated with a first boneportion, the stabilizing structure comprising a first transverseaperture; and (b) a fastening assembly at least partially extendingthrough the first transverse aperture, the fastening assembly comprisingan engaging member and a compression member: (i) wherein the engagingmember engages a second bone portion; (ii) wherein the compressionmember contacts and interacts with the engaging member; (iii) whereinthe compression member contacts the second bone portion; (iv) whereinthe compression member facilitates a sliding movement of the engagingmember with respect to the first transverse aperture; and (v) whereinthe compression member at least indirectly interacts with thestabilizing structure to facilitate controlled movement between thefirst and second bone portions; wherein the controlled movementcomprises substantial preclusion of rotation of the first and secondbone portions with respect to one another as well as compressing thefirst and second bone portions with respect to one another.
 15. Theapparatus for treating bone maladies of claim 14, further comprising aninsert at least partially extending through the first transverseaperture and comprising a second transverse aperture; wherein thefastening assembly at least partially extends through the secondtransverse aperture.
 16. The apparatus for treating bone maladies ofclaim 15, wherein the compression member at least indirectly interactswith the insert to facilitate controlled movement between the first andsecond bone portions.
 17. The apparatus for treating bone maladies ofclaim 16, wherein the compression member comprises a shoulder that abutsagainst a portion of the insert.
 18. The apparatus for treating bonemaladies of claim 15, wherein adjusting the compression member tensionsthe engaging member to compress the first and second bone portions withrespect to one another.
 19. The apparatus for treating bone maladies ofclaim 15, wherein the compression member is at least partially nestedwithin a portion of the engaging member.
 20. The apparatus for treatingbone maladies of claim 19, wherein the compression member comprises afirst threaded portion and the engaging member comprises a secondthreaded portion; wherein the first and second threaded portionscooperate with one another such that adjusting the compression membertensions the engaging member to compress the first and second boneportions with respect to one another.
 21. The apparatus for treatingbone maladies of claim 15, wherein the stabilizing structure is acompression plate.
 22. The apparatus for treating bone maladies of claim15, wherein the stabilizing structure is a periarticular plate.
 23. Theapparatus for treating bone maladies of claim 15, wherein the insertsnaps into the first transverse aperture.
 24. The apparatus for treatingbone maladies of claim 15, wherein the insert is integral with thestabilizing structure.